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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Nipple
510(k) Number K923577
Device Name BREAST SHELLS
Applicant
Medela, Inc.
P.O. 660
Mchenry,  IL  60051
Applicant Contact STEPHEN D SMITH
Correspondent
Medela, Inc.
P.O. 660
Mchenry,  IL  60051
Correspondent Contact STEPHEN D SMITH
Regulation Number880.5630
Classification Product Code
HFS  
Date Received07/20/1992
Decision Date 01/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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